中国药房2009，Vol.20Issue(33)：2616-2618,3.
苦参素片与苦参素胶囊的药动学和生物等效性研究
Pharmacokinetics and Bioequivalence of Matrine Tablets and Matrine Capsules in Healthy Volunteers
靳怡然 1杜英峰 2许慧君2
作者信息
- 1. 河北医科大学第二医院药剂科,石家庄市,050000
- 2. 河北医科大学药学院药物分析教研室,石家庄市,050017
- 折叠
摘要
Abstract
OBJECTIVE: To compare the pharmacokinetic parameters between matrine tablets and matrine capsules in healthy volunteers and evaluate the bioequivalence of the two formulations. METHODS: 18 healthy volunteers were assigned to receive matrine tablets (test formulation, 600rag) and matrine capsule (reference formulation) respectively q.d on empty stomach. The plasma concentrations of oxymatrine before and after medication were determined by HPLC and the pharma-cokinetic parameters (calculated by oxymatrine) were calculated. RESULTS: The pharmacokinetic parameters of matrine tablets vs. Matrine capsules in healthy volunteers were as follows: t_(1/2): (1.51±0.62) h vs. (1.53±0.54) h; T_(max): (1.35±0.13) h vs.(1.29±0.13) h; C_(max): (730.86±101.13) ng·mL~(-1) vs.(729.58±74.35) ng·mL~(-1); AUC_(0～8): (2 579.1±244.4) ng·h·mL~(-1) vs.(2 505.7±223.5) ng·h·mL~(-1); AUC_(0～∞): (2 754.1±331.8) ng·h·mL~(-1) vs.(2 659.4±253.5) ng·h·mL~(-1).The relative bioavailability of matrine tablets(calculated by oxymatrine) was(103.7±13.3)%. CONCLUSION: There are no significant di-fferences between matrine tablets and matrine capsule in main pharmacokinetic parameters, which were in conformity with the presumption of bioequivalence between different individuals, different periods or different dosage forms. The two ormulations are bioequivalent.关键词
苦参素/氧化苦参碱/生物利用度/生物等效性Key words
Matrine/ Oxymatrine/ Bioavailability/ Bioequivalence分类
医药卫生引用本文复制引用
靳怡然,杜英峰,许慧君..苦参素片与苦参素胶囊的药动学和生物等效性研究[J].中国药房,2009,20(33):2616-2618,3.
